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Recruiting NCT05739123

Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring

— Observational Pregnancy Related Pregnancy Complications Pregnancy, High Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Relugolix-Containing Product.
Who it may be relevant to
Registry conditions: Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk. Basic parameters: from 0 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable.

Detailed description

The outcomes of interest include major congenital malformation (MCM; primary outcome), minor congenital malformation, spontaneous abortion (SAB), stillbirth, elective termination, small for gestational age (SGA), preterm birth, postnatal growth deficiency, and infant developmental deficiency.

Pregnancy outcomes will be assessed throughout pregnancy, with data collection occurring at enrollment, the end of the second trimester, and pregnancy outcome. Infant outcomes will be assessed throughout the infant's first year of life, with active data collection by the registry occurring at 4 and 12 months after delivery. Enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable, will serve as data reporters to the registry.

The registry is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are documented in patients' medical records during the course of medical care will be collected. No additional laboratory tests or HCP assessments will be required as part of this registry.

Interventions

  • Drug Relugolix-Containing Product
    Any relugolix-containing therapy

Primary outcome measures

  • Major Congenital Malformation (MCM) [Time frame: Up to 10 years]
Secondary outcome measures (8)
  • Minor congenital malformations [Time frame: Up to 10 years]
  • Spontaneous abortion (SAB) [Time frame: Up to 10 years]
  • Stillbirth [Time frame: Up to 10 years]
  • Elective termination [Time frame: Up to 10 years]
  • Preterm birth [Time frame: Up to 10 years]
  • Small for gestational age (SGA) [Time frame: Up to 10 years]
  • Postnatal growth deficiency [Time frame: Up to 10 years]
  • Infant developmental deficiency [Time frame: Up to 10 years]

Eligibility criteria

Inclusion criteria

  • Woman of any age
  • Currently or recently pregnant
  • Consent to participate
  • Authorization for her HCP(s) to provide data to the registry

Cohort 1

  • Exposure to at least one dose of relugolix-containing therapy at any time during pregnancy

Cohort 2

  • Diagnosis of a condition for which relugolix-containing therapy may be prescribed and who are not exposed to relugolix containing therapy at any time during pregnancy

Exclusion criteria

The following will be eligible for enrollment, included in supplementary analyses, but excluded from the analysis population:

  • Occurrence of pregnancy outcome prior to first contact with the registry coordination center (retrospectively enrolled)
  • Exposure to known teratogens and/or investigational medications during pregnancy
  • Lost to follow-up

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • PPD — Wilmington

Identifiers

NCT: NCT05739123 · MVT-601A-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗